Effect of Diet and Physical Activity on Incidence of Type 2 Diabetes (PREVIEW)

This study is ongoing, but not recruiting participants.

Sponsor:

Anne Birgitte Raben

ClinicalTrials.gov Identifier:

NCT01777893

First Posted: January 29, 2013

Last Update Posted: June 1, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Type-2 diabetes is one of the fastest growing chronic diseases worldwide. This trend is mainly driven by a global increase in the prevalence of obesity. The PREVIEW study has been initiated to find out the most effective lifestyle-components (diet and physical activity) in the prevention of Type-2 diabetes. The project consists of a randomized lifestyle-intervention with the more specific aim to determine the preventative impact of a high-protein and low-GI diet in combination with moderate or high intensity physical activity compared with a moderate-protein and moderate GI diet in combination with the same activity levels on the incidence of Type-2 diabetes in predisposed, pre-diabetic children, young and older adults.

The trial will be performed in 6 EU countries (Bulgaria, Denmark, Finland, Spain, Netherlands, UK) and Australia and New Zealand.

A total of 2,500 overweight or obese adult participants (25-70 y) as well as 150 children and adolescents aged 10—18 y) will be recruited. All adult participants are first treated by a low-calorie diet for 8 weeks, with an aim to reach ≥ 8% weight reduction. Children and adolescents are treated separately with a conventional weight-reduction diet, with-out a specific aim for absolute weight loss.

The adult participants are randomized into two different diet interventions and two exercise interventions for a total of 148 weeks. This period aims at preventing Type-2 diabetes by weight-maintenance (prevention of relapse in reduced body weight) and by independent metabolic effects of diet and physical activity.

The primary endpoint of the study is the incidence of Type-2 diabetes in the adults during 3 years (156 weeks) according to diet (high protein/low-GI versus moderate protein/moderate-GI, adjusted for physical activity), based on a 75 g oral glucose tolerance test and/or HbA1c.

For children and adolescents:

Change in insulin resistance at 2 years after randomization to high protein versus moderate protein diet, measured by insulin resistance analyzed by the homeostatic model (HOMA-IR) as well as physiological improvement of health with respect to pre-diabetic characteristics.

Our hypothesis is that a high-protein, low-GI diet will be superior in preventing type-2 diabetes, compared with a moderate protein, moderate GI diet, and that high-intensity physical activity will be superior compared to moderate-intensity physical activity.

The effects of stature (height; proportion leg-length/height) in adults and changes in stature in children and adolescents, on the changes in relationship between reduction in body weight, body fat and insulin sensitivity [ Time Frame: 3 years ]

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Ages Eligible for Study:

10 Years to 70 Years (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

For adults:

Age 25 - 70 years:

From mid 2013 - mid 2014, subjects aged 25-45 and 55-70 years were enrolled. From mid 2014, subjects aged 46-54 years were also enrolled.

Overweight or obesity status BMI>25 kg/m2

Pre-diabetes The criteria from WHO/IDF (International Diabetes Foundation) for assessing pre-diabetes will be used as the formal inclusion criteria (at screening), i.e. having:

Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity program);

A recent surgical procedure until after full convalescence (investigators judgement);

Transmissible blood-borne diseases e.g. hepatitis B, HIV;

Psychiatric illness (e.g. major depression, bipolar disorder).

Medication:

Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months.

Blood donation or transfusion within the past 1 month before baseline or CID's;

Self-reported eating disorders;

Pregnancy or lactation, including plans to become pregnant within the next 36 months.

No access to either phone or Internet (this is necessary when being contacted by the instructor's during the maintenance phase);

Adequate understanding of national language;

Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the protocol.

Laboratory screening:

If all of the above criteria are satisfied, the participant is eligible for a glucose tolerance test (blood at 0 and 120 mins), and blood glucose concentrations are analyzed immediately (Haemocue). In addition full blood count, urea, and electrolytes may be analyzed as a further safety evaluation. Having normal (i.e. not prediabetic) glucose concentrations at 0 and 2h of OGTT at any stage of the study is not an exclusion criterion.

ONLY IF the glucose tolerance test meets the entry criteria for the study, the remaining samples are sent to the local laboratory for a safety check, with the following exclusion criteria:

Alanine Transaminase (ALT) and/or Aspartate Transaminase (AST) >3 times the Upper Limit of Normal (local laboratory reference values) Or any other significant abnormality on these tests which in the investigators opinion may be clinically significant and require further assessment

Electrocardiography (ECG). Any abnormality which in the opinion of the investigator might indicate undiagnosed cardiac disease requiring further assessment (e.g. significant conduction disorder, arrhythmia, pathological Q waves). This is done in adults 55-70 years of age.

After LCD phase (in adults):

Failure to reach at least 8% weight reduction during the LCD phase. This leads to exclusion from the intervention.

Note:

The listed inclusion and exclusion criteria are applied at screening;

Having normal (i.e. not pre-diabetic) glucose concentrations at 0 and 2 h of OGTT at any stage of the study after screening is not an exclusion criterion

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777893